Changes to the requirements for submitting to the PBAC that take effect July 2015

PBAC

The Department of Health has updated the way submissions are made to the Pharmaceutical Benefits Advisory Committee for listing medicines on the PBS. The documentation requirements have been revised and simplified.  The new requirements are as follows:

  • Supply the whole submission and any accompanying calculations and models in electronic format on two clearly labelled USB storage devices. The devices must be tested to ensure that they are fully accessible; USB devices that cannot be accessed will be returned, noting that this may occur after the closing date for submissions. 
  • Sponsors must supply the whole submission and any accompanying calculations and models in electronic format on two clearly labelled USB storage devices (with any spreadsheet compatible with Microsoft Excel 2010, any word-processed document compatible with MS Word 2010, and any other software package consistent with Part I, Subsection 5.2). Ensure that all components of these electronic documents, spreadsheets and analyses are fully accessible (eg do not have password protection) and fully enabled to allow all document text, tables and figures to be accessed for copying and fully executable to allow all spreadsheet cells and all statistical or decision analysis input variables to be changed.

For more details, go to: http://www.pbs.gov.au/info/news/2015/07/changes-to-requirements-for-submitting-to-pbac

Michael Wonder

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Michael Wonder

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